| CTRI Number |
CTRI/2022/03/040799 [Registered on: 04/03/2022] Trial Registered Prospectively |
| Last Modified On: |
02/03/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
The effect of the drug dexmedetomidine in nebulized form in bronchoscopy as a pre-medication |
|
Scientific Title of Study
|
Effectiveness of nebulized dexmedetomidine for premedication in flexible bronchoscopy in Indian patients- a prospective, randomized, double blinded study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Thomas Antony |
| Designation |
Senior resident |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Room No:5
Respiratory Medicine department,
Kasturba medical college Hospital, Attavar
Mangalore
Respiratory Medicine department,
Kasturba medical college,
Mangalore
Dakshina Kannada
KARNATAKA
575003
India |
| Phone |
8547437931 |
| Fax |
|
| Email |
t.antony5@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Thomas Antony |
| Designation |
Senior resident |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Respiratory Medicine dept,
Kasturba medical college,
Mangalore
KARNATAKA
575003
India |
| Phone |
8547437931 |
| Fax |
|
| Email |
t.antony5@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Preetam Acharya |
| Designation |
Professor and Head |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Room No:5, First floor
Respiratory Medicine department,
Kasturba medical college Hospital, Attavar
Mangalore
Respiratory Medicine department,
Kasturba medical college Hospital, Attavar
Mangalore
Dakshina Kannada
KARNATAKA
575003
India |
| Phone |
9448953430 |
| Fax |
|
| Email |
preetam.acharya@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal Academy of Higher Education |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical college |
| Address |
Kasturba Medical college,
mangalore |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Thomas Antony |
Kasturba Medical College |
Room No:5
First floor,
Kasturba Medical College Hospital, Attavar, Mangalore
Dakshina Kannada
KARNATAKA |
8547437931
t.antony5@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical college, Mangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J470||Bronchiectasis with acute lower respiratory infection, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nebulized Dexmedetomidine |
Dexmedetomidine at a dose of 1mcg/Kg diluted with 0.9% saline to make up to 5ml for nebulization. As the drug is given via nebulizer, it takes 10 minutes to administer the drug. Once the drug is given bronchoscopy is initiated and continued till the procedure is over. |
| Comparator Agent |
Normal Saline nebulization |
0.9% saline 5 ml for nebulization.
As the drug is given via nebulizer, it takes 10 minutes to administer the drug. Once the drug is given bronchoscopy is initiated and continued till the procedure is over. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All patients in the age group 18 to 65 years undergoing flexible bronchoscopy in the Department of Respiratory Medicine. |
|
| ExclusionCriteria |
| Details |
a. Patients with known or suspected allergy to lignocaine or Dexmedetomidine
b. Patients with renal or hepatic insufficiency
c. Patients with seizure disorder
d. COPD patients with FEV1 <50%
e. Patients with psychiatric disorder
f. Hemodynamically unstable patients including cardiac failure
g. Heart rate <50 beats per min or second or third degree heart block
h. Patients with body weight more than 70kg.
i. Pregnancy and lactation
j. Patients posted for bronchoscopy and not consenting for study.
h. Patients with nasal abnormalitues/infectionn
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Composite score during the bronchoscopy procedure.
2. Numerical Rating Scale (NRS) for pain intensity and distress.
3. Visual Analogue Scale (VAS) for cough.
4. Ramsay sedation score (RSS).
5. Ease of bronchoscopy procedure as assessed by Observer B
|
Primary outcomes will be assessed during bronchoscopy and at the end of bronchoscopy.
Secondary parameters like vital parameters will be assessed at baseline, at the start of the procedure, 5 minutes into the procedure, 10 minutes, at the end of scopy and 10 minutes post procedure.
Patient is assessed 2 hours post procedure for other variables.
Theres no follow up required for the study. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Willingness for repeatability of the procedure as felt by patient.
2. Variations in heart rate (HR), blood pressure (BP), oxygen saturation (SpO2).
3. Duration of bronchoscopy procedure
4. Procedures underwent during bronchoscopy (Bronchial washing, broncho-alveolar lavage (BAL), bronchial brushing, endobronchial biopsy, transbronchial needle aspiration (TBNA), or transbronchial lung biopsy (TBLB) |
0,1year |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/03/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A written informed consent will be taken from all study participants. For patients who meet the inclusion criteria, demographic details like age, gender, height, weight, BMI, prior bronchoscopy procedure, current indication for bronchoscopy and the procedures done during bronchoscopy will be recorded in the study proforma. Patients undergoing FB will be randomized in a one is to one ratio as per a computer generated randomization table and will be allocated to any of the two groups (Group A or Group B). Patients in group A will receive nebulized dexmedetomidine at 1 mcg/Kg, diluted with 0.9% saline into 5 ml. Patients in group B receive 5 ml of 0.9% saline nebulization prior to bronchoscopy. A composite scoring will be done by observer C at the level of nasopharynx, during passage through trachea and when crossing the carina. Heart rate, cardiac rhythm. Non-invasive blood pressure (NIBP), respiratory rate, and pulse oximetry saturation will be recorded before the start of bronchoscopy, monitored continuously during the procedure till its completion and 10 minutes post procedure. Patient is further assessed after 24 hours and asked to give their opinion on the procedure, the quality of sedation, discomfort, any adjustment needed in the dose of sedation and willingness for a repeat procedure if required |